To conduct a pilot study to evaluate the effects of new GES programming settings on abdominal pain in patients with gastroparesis and existing GES devices, whose abdominal pain has so far been refractory to drugs and/or devices.
Full Title of Study: “Gastric Electrical Stimulation for Treating Abdominal Pain in Patients With Gastroparesis”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: April 1, 2020
Eligible patients will undergo detailed pain assessments as well as non-invasive physiologic assessment. Patients existing GES devices will be reprogrammed to new setting for 4 week and their GI symptoms including pain will be evaluated by a daily diary. At the end of 4 weeks detailed pain assessments and noninvasive physiologic assessments will be repeated.
- Device: Enterra
- To measure validated and subjective pain scores among patients with an existing GES device, and who have a trial of new settings directed at abdominal pain and compare their pain scores to each patient baseline symptoms, done with their previous GES settings.
Arms, Groups and Cohorts
- Gastroparesis patients with abdominal pain
- Patients with gastroparesis who have had an Enterra device in place for at least two months who continue to have moderate to severe abdominal pain.
Clinical Trial Outcome Measures
- Abdominal Pain
- Time Frame: 4 weeks
- Abdominal Pain by Brief Pain Inventory. The values are 0-10, with 10 being worse outcome.
Participating in This Clinical Trial
- Should be able to give informed consent for the study
- Has Enterra GES device in place for at least 2 months
- Continue to have moderate to severe abdominal pain on at least one pain questionnaire or >5 score (on a scale of 0-10 for pain) on the VAS questionnaire for at least 2 months.
- Abdominal pain should be either persistent; for example, daily for at least >1 hour, be chronic for >2 months, and refractory to original Enterra GES settings
- Unable to provide informed consent
- Any other active health problems that would render patient unable to complete the study
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Louisville
- Provider of Information About this Clinical Study
- Principal Investigator: Thomas Abell, Professor – University of Louisville
- Overall Official(s)
- Thomas Abell, MD, Principal Investigator, University of Louisville
- Overall Contact(s)
- Thomas Abell, (502)852-6991, email@example.com
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